Lohxa Recalls Chlorhexidine Gluconate Oral Rinse Due to Bacterial Contamination
Lohxa LLC is recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12%, due to contamination with Burkholderia lata bacteria.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
Lohxa LLC is recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit dose cups. The recall was initiated because the repackaged product was found to be contaminated with the bacteria Burkholderia lata.
The affected product is distributed by Lohxa, located in Worcester, MA, and carries the NDC 70166-027-15. A total of 329 cartons were distributed to medical facilities in Florida and New York. The recall includes specific lots with expiration dates ranging from January 2021 to March 2021.
This is an FDA Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Medical facilities should stop using the affected product and contact Lohxa for instructions on returning or disposing of the stock.
The recalled product
- Product
- Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15
- Manufacturer
- Lohxa LLC
- Category
- Drug — Oral Rinse
- Affected units
- 329
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot #: T09101A
- Exp 01/2021
- T08292A
- T10011A
- Exp 02/2021
- T10223A
- M10193A
- Exp 03/2021
Distribution
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